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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021336
Receipt No. R000024607
Scientific Title Phase 1 study to evaluate the safety and efficacy of jyuzentaihoto in infantile anal fistula
Date of disclosure of the study information 2016/03/04
Last modified on 2017/07/20

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Basic information
Public title Phase 1 study to evaluate the safety and efficacy of jyuzentaihoto in infantile anal fistula
Acronym Safety and efficacy of jyuzentaihoto in infantile anal fistula
Scientific Title Phase 1 study to evaluate the safety and efficacy of jyuzentaihoto in infantile anal fistula
Scientific Title:Acronym Safety and efficacy of jyuzentaihoto in infantile anal fistula
Region
Japan

Condition
Condition infantile anal fistula
Classification by specialty
Gastroenterology Gastrointestinal surgery Pediatrics
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We are going to evaluate the safety and efficacy of jyuzentaihoto in infantile anal fistula
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes rate of cure after two and four weeks
Key secondary outcomes The influence on gut flora and the safety after the administration of jyuzentaihoto

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 jyuzenntaihoto
Interventions/Control_2 observe
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
0 years-old <=
Age-upper limit
2 years-old >=
Gender Male and Female
Key inclusion criteria With anal fistula, no subjective symptoms,
Key exclusion criteria Any of the following: currently receiving a drug therapy, currently having chronic diseases such as heart, lung, kidney, gastrointestinal, and inflammatory diseases, suffering from invasive cancer within five years, suffering from non-invasive cancer within a year, and having taken Kampo medicine within 2 weeks.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiko Ogawa
Organization Kanazawa University
Division name Department of Kampo Medicine
Zip code
Address 13-1,Takara-machi, Kanazawa
TEL 076-265-2918
Email okeiko@med.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiko Ogawa
Organization KKanazawa University
Division name Department of Kampo Medicine
Zip code
Address 13-1,Takara-machi, Kanazawa
TEL 076-265-2918
Homepage URL
Email okeiko@med.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University
Institute
Department

Funding Source
Organization Kanazawa University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 金沢大学附属病院、松任石川中央病院

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 04 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2013 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 01 Day
Last follow-up date
2016 Year 08 Month 31 Day
Date of closure to data entry
2016 Year 08 Month 31 Day
Date trial data considered complete
2016 Year 09 Month 30 Day
Date analysis concluded
2016 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 03 Month 04 Day
Last modified on
2017 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024607

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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